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510(k) K230657

BTL-99-OC by BTL Industries, Inc. — Product Code QCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2024
Date Received
March 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device Class
Class II
Regulation Number
882.5802
Review Panel
NE
Submission Type

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

Other clearances by BTL Industries, Inc.

  • K252561 — BTL-754FF (February 18, 2026)
  • K250309 — BTL-199 (August 7, 2025)
  • K243290 — BTL-785MJ (May 9, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241270 — BTL-754 (January 30, 2025)
  • K242532 — BTL-785BNF-E (December 13, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233849 — BTL-499 (April 23, 2024)
  • K233604 — BTL-785S (March 28, 2024)
  • K232937 — BTL-899M (December 26, 2023)

Other clearances for product code QCI

  • K243459 — Ultimate rTMS for OCD (M-series) (April 17, 2025)
  • K233742 — CloudTMS Edge for OCD (December 22, 2023)
  • K231350 — OCD MT Cap (85-00397-000) (June 8, 2023)
  • K221129 — CloudTMS for OCD (March 10, 2023)
  • K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced T (May 6, 2022)
  • K193006 — MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (August 9, 2020)
  • K183303 — Brainsway Deep TMS System (March 8, 2019)
  • DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (August 17, 2018)